Professional Documents
Culture Documents
The Perfect Manual
The Perfect Manual
The
Perfect
Manual
A Guide to Lean
Management Systems
ISO 9001:2008
ISO 13485:2003
ISO 14001:2004
BS OHSAS 18001:2007
and other standards
Seventh edition
Chapter 1
Foreword
Chapter 1 Foreword
Page 1 of 90
Chapter 1 Foreword
Page 2 of 90
Chapter 1 Foreword
Page 3 of 90
1.2 Introduction
Back to Table of Contents
Through my work as an auditor and a consultant with dozens
of companies in the United States, Great Britain, Mexico,
Japan, Russia and Southeast Asia, I have witnessed the
implementation of numerous quality management systems
(QMS) and environmental management systems (EMS).
Assessing various systems, I realized that what seemed to be
a simple task of creating a quality or environmental
management system manual and documenting a companys
commitment to a particular standard can create significant
difficulties for businesses of various sizes, in diverse
industries, in different countries. Simply speaking, during my
career in the registration and consulting businesses, I have
not yet seen a manual during an initial review that addressed
all the requirements of applicable standards.
I wrote this book for two reasons. First, I wanted to help
companies overcome the tedious and time-consuming task of
developing a quality or environmental manual by showing an
example of a manual for ISO 9001 2008 (ISO 9001) [2]
standard. Second, and more important, the purpose of this
book is to show a method for creating a quality, environmental
or any other manual, so that in the future, you can develop a
manual for any standard or regulation, whether it is ISO
13485, AS9100, FDAs 21 CFR 820, European Council Directive
93/42/EEC or any other.
This book describes a model of a quality manual and several
key processes to support the initial release of the manual.
Chapter 1 Foreword
Page 4 of 90
Chapter 1 Foreword
Page 5 of 90
Page 6 of 90
Chapter 1 Foreword
Page 7 of 90
Chapter 1 Foreword
Page 8 of 90
Chapter 1 Foreword
Page 9 of 90
Page 10 of 90
Page 11 of 90
Chapter 1 Foreword
Page 12 of 90
Page 13 of 90
Chapter 1 Foreword
Page 14 of 90
(E:)
Management system
Archive documents
Current documents
Documentation Master List 01
Document Template Procedure 01
and so on
External documents
ISO 9000:2005 Standard
ISO 9001:2008 Standard
ISO 9004:2000 Standard
Chapter 1 Foreword
Page 15 of 90
Page 16 of 90
Chapter 1 Foreword
Page 17 of 90
Chapter 2
Quality
Manual 101
2
Page 18 of 90
a)
b)
Page 19 of 90
c)
A table of contents,
Company information,
Procedure index,
Manual-to-standard correspondence table, if your
manual numbering differs from the standard, and
Standard-to-manual correspondence table, if you
develop an integrated manual.
Page 20 of 90
Page 21 of 90
Page 22 of 90
Page 23 of 90
Page 24 of 90
Page 25 of 90
Page 26 of 90
Page 27 of 90
Chapter 3
Getting
Started
Page 28 of 90
3.1 Documentation
Structure
Back to Table of Contents
ISO 10013, Guidelines for Developing Quality Manuals, gives
an example of a documentation structure for ISO 9001 quality
systems. While this document suggests using a three-level
structure, most companies implement four-level
documentation structures to include records, as required by
element 4.2.4 Control of quality records, of the ISO
9001:2008 Standard. A typical four-level documentation
structure includes: Quality Manual, Procedures, Instructions
and Records.
Actually, the documentation structure starts from the policy.
The policy defines, among others, commitments to what
standard a company intends to comply with. If you choose to
use this approach, your quality management system
documentation will have five levels, similar to the structure
below:
Quality policy
Quality Manual
Procedures
Instructions
Records
level
level
level
level
level
1
2
3
4
5
Page 29 of 90
Page 30 of 90
Page 31 of 90
Page 32 of 90
Page 33 of 90
Page 34 of 90
2
3
Page 35 of 90
Page 36 of 90
Chapter 4
Key
Processes
Page 37 of 90
Page 38 of 90
Page 39 of 90
Page 40 of 90
Page 41 of 90
Page 42 of 90
Document title
Documentation Master List
Template Procedure
Documentation Management
Procedure
Organizational Chart
COO
------1
Distribution Matrix
QA R&D Fin
1
----1
----1
----1
Page 43 of 90
(2)
Page 44 of 90
Page 45 of 90
Page 46 of 90
Organizational Chart
N/A
Yes
Yes
--N/A
---
--Yes
N/A
-------
Yes
---
---
N/A
Documentation
Management Procedure
Template Procedure
Document title
Documentation Master
List
Reference Matrix
Page 47 of 90
Page 48 of 90
Page 49 of 90
Page 50 of 90
4.7 Documentation
Management Procedure
Back to Table of Contents
Element 4.2.3, Control of documents, of the ISO 9001
standard requires the establishment of a documented
procedure for this area. A quality manual is a document and
therefore is subject to element 4.2.3 requirements. So, before
we start working on the quality manual, we have to develop a
procedure to define methods for the creation, maintenance
and obsolescence of the quality manual and other documents
of our system.
The standard, as well as many companies around the world,
call this function documentation control. Born in the Soviet
Union under what was undoubtedly one of the most
totalitarian regimes in the world, I am averse to the word
control. There are also indications that this word started to
be considered misleading in the Western world as well. Quality
Control discipline, for example, was transformed into Quality
Assurance, emphasizing prevention rather than the detection
of problems. The American Society for Quality Control (ASQC)
renamed itself in 1997 to the American Society for Quality
(ASQ). So lets also switch from control to management to
demonstrate our awareness of contemporary thinking, and
manage our documentation system with a Documentation
Management Procedure.
Page 51 of 90
Page 52 of 90
Page 53 of 90
Jerry Goal,
President
Lisa Cash
Director, Finance
Mark Wright
Director, QMS
Danette Sale
Director, Sales
Page 54 of 90
Page 55 of 90
Page 56 of 90
Page 57 of 90
Page 58 of 90
Page 59 of 90
Page 60 of 90
Page 61 of 90
Page 62 of 90
Page 63 of 90
Page 64 of 90
Page 65 of 90
Page 66 of 90
Page 67 of 90
DCR number;
Change type: permanent or temporary;
Originator name;
Change description;
Reason for change: Improvement, Correction of
previous releases or others;
List of other documents affected by the change;
Disposition of existing stock of physical inventory;
Validation record;
Review and approval records, including regulatory
approval, if applicable;
Page 68 of 90
Page 69 of 90
Page 70 of 90
4.16 Summary
Back to Table of Contents
In summary, to release our Quality manual, we need to
develop and release the following core documents:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Page 71 of 90
Page 72 of 90
Page 73 of 90
Chapter 5
Customizing
your Quality
Manual
5
Page 74 of 90
5.1 Navigation
Back to Table of Contents
Whether you are creating your quality manual from scratch or
tuning-up an existing manual, it is a good idea to keep the
numbers of the elements of your manual referenced to the
standard. A simple table, similar to the one below will serve
as a good map.
Sec
1
2
3
4
5
5.1
5.2
6
6.1
6.2
6.3
6.4
6.5
6.6
The manual
Process / Clause
Table of contents
Company information
Definitions
Scope
Quality management system
General requirements
Documentation requirements
Management responsibility
Management commitment
Customer focus
Quality policy
Planning
Responsibility, authority and
communication
Management review
ISO 9001:2008
Clause
--------4
4.1
4.2
5
5.1
5.2
5.3
5.4
5.5.
5.6
Page 75 of 90
14001
--------4
4.1
4.2
5
--5.1
5.2
5.3
5.4
5.5
--------4
4.1
4.4.4
--4.2
4.2
----4.3
4.4.1
5.6
4.6
Manual
Process / Clause
Table of contents
Company information
Definitions
Scope
Management system
General requirements
Documentation requirements
Management responsibility
Environmental policy
Management commitment
Customer focus
Quality policy
Planning
Responsibility, authority and
communication
Management review
Sec
1
2
3
4
5
5.1
5.2
6
6.3
6.1
6.2
6.3
6.4
6.5
6.6
Page 76 of 90
Page 77 of 90
Page 78 of 90
Page 79 of 90
Page 80 of 90
5.5.1
Responsibility and
authority
Resource Management
Procedure
Organizational Chart HO
Site: Ontario
Resource
Management
Procedure
Organizational
Chart Ontario
Page 81 of 90
Company information
Site: Ontario
Title
ISO 9001:2008
QW Enterprises
LLPs Ontario
location does not
perform design
function, therefore,
design is excluded
for this facility
Corporate
Page 82 of 90
Page 83 of 90
Chapter 6
Documents
6
Chapter 6 Documents
Page 84 of 90
Chapter 6 Documents
Page 85 of 90
Chapter 7
Afterword
Chapter 7 Afterword
Page 86 of 90
7.1 Afterward
Back to Table of Contents
If you followed advices of this book and, using the referenced
documents, created and released your first DCR, you have
definitely saved yourself a lot of time and money, as I
promised in the beginning. However, just having manual and
key procedures will not bring a company an effective quality
management system. An effective management system is one
that practically represents your organizations processes and is
understood and used by the organization. Make sure that
everyone knows and understands your quality manual and
policy. Make sure that procedures and instructions are used by
the functions for which they were written.
So whats the next step? Continue developing, validating and
implementing other procedures and instructions to cover all
elements of the standard as well as your specific processes.
Encourage everyone to provide input to relative documents.
While developing second-level procedures, do not forget that
their intent is not only to define your processes, but also to
support particular elements of your quality manual. Before
release, make sure that your second-level procedures address
all elements of the manual where they are referenced. To
locate all occurrences of a title of a procedure in the manual,
you may use the Find function in your word processor or the
Procedure index in our Quality Manual.
I hope this book helped you to get started. Good luck with
your efforts in creating a quality management system that
meets the requirements of all applicable standards and
regulations. I wrote this book for you, gentle reader, and
Chapter 7 Afterword
Page 87 of 90
Chapter 7 Afterword
Page 88 of 90
Chapter 7 Afterword
Page 89 of 90
7.3 References
Back to Table of Contents
[1]
[2]
[3]
[4]
[5]
[6]
[7]
Chapter 7 Afterword
Page 90 of 90